Packaging system for transdermal drug delivery systems

Abstract

A device and method for stabilizing a drug, particularly a chiral drug or the active enantiomer(s) thereof, in a carrier composition of a transdermal delivery system prior to the systems use by providing a product packaging system to prevent or control degradation reactions that can result from certain packaging materials and moisture contamination, while at the same time providing a child-resistant wrapping for the transdermal system.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS[0001]The present application claims the benefit of U.S. Provisional Application Ser. No. 60 / 285,976 filed Apr. 23, 2001, and is a continuation-in-part of U.S. patent application Ser. No. 09 / 804,926 filed on Mar. 13, 2001, abandoned, which claims the benefit of U.S. Provisional Application Ser. No. 60 / 189,333 filed Mar. 14, 2000, which are expressly incorporated by reference in their entirety.BACKGROUND OF THE INVENTION[0002]1. Field of the Invention[0003]The present invention relates to stabilizing a drug in a packaged product. More specifically, the present invention relates to a packaging system for the prevention of degradation in pharmaceutical products, particularly controlled release drug delivery devices such as transdermal systems.[0004]2. Description of Related Art[0005]The use of transdermal drug delivery systems or “patches” as a means to topically administer a drug is well known. Such systems dissolve or disperse the drug into a ca...

AI Technical Summary

Benefits of technology

[0020]It is therefore an object of this invention to provide a cost efficient packaging system for a transdermal drug delivery system that improves protection from contamination, such as the crystallization or degradation, of the drug, and from other environmental factors, during storage of the system prior to its use.

[0023]It is a further object of this invention to provide a packaging system for a transdermal system that improves the stability of chiral drugs and pharmaceutically active enantiomers thereof contained in a transdermal system during its storage prior to its use.

[0025]The foregoing and other objects are achieved with this invention by providing a pouch for a transdermal system that is inert to the components of the transdermal system, water vapor permeable to permit removal of moisture from within the pouch, and child-resistant. The pouched transdermal system is further sealed within a substantially water vapor impermeable product package that contains a desiccant material. The drug incorporated in the transdermal system remains substantially solubilized and stable in the carrier composition of the transdermal system free of contamination from the desiccant or moisture while the system is stored in the product package prior to its use.

Problems solved by technology

Moreover, certain isomers may actually be deleterious rather than simply inactive or inert.

For example, U.S. Pat. No. 5,008,110 discloses that certain polyolefin materials used for transdermal devices tend to absorb lipophilic solvents and / or enhancers, which can significantly decrease the drug's solubility in the carrier composition, as well as cause physical failure of the packaging material.

U.S. Pat. No. 4,943,435 discloses that nicotine will adversely affect many common transdermal system component materials such as adhesives, membranes, backings and release liners.

It has been additionally discovered that methylphenidate, a chiral drug that exists as four enantiomers of which only one is currently known to be significantly pharmacodynamically active, is unstable in the presence of certain types of packaging materials used for transdermal systems.

It is further known that common environmental factors such as the presence of water (in liquid or vapor form), air and light can adversely affect the stability of some drugs.

Such environmental factors can further affect the solubility of the drug in the carrier composition, which in turn can also significantly impact the shelf-life of the transdermal system.

As a result, packaging materials produced of multiple layers, many incorporating metal foils, are typically required to provide an environmental barrier.

Such packaging requirements often result in higher costs for materials and production, and require controlled production to achieve a uniform and desired level of moisture impermeability.

Such packages may be difficult to open without the aid of mechanical means such as scissors, and, even the best, may still be moisture permeable to some extent.

Although careful control of the manufacturing conditions and packaging materials can reduce the presence of moisture within a sealed pouch containing a transdermal system, the further use of a desiccant is still often required.

The '400 patent does not teach the use of a pouch for transdermal systems that is permeable to moisture vapor while at the same time meeting the requirements for child-resistant packaging.

None of the related art teaches a cost efficient packaging system for transdermal drug delivery systems that incorporates within a container use of a desiccant and a moisture permeable pouch to hold the transdermal system which is inert to the drug and other transdermal components, in order to prevent degradation reactions of the drug that can be caused by contamination from certain packaging materials and moisture, while also providing a child-resistant wrapping for the transdermal system.

In addition, none of the related art teaches the importance of controlling packaging materials and moisture to prevent degradation reactions of chiral drugs or pharmaceutically active enantiomer(s) thereof in transdermal systems.

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